The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE

Not Applicable

Completed

• Conditions: Hypoxic-Ischemic Encephalopathy
• Interventions: Dietary Supplement: Minimal enteral nutrition; Dietary Supplement: Distilled water

• Registration Number: NCT06344286
• Lead Sponsor: Istanbul Training and Research Hospital

Brief Summary

The goal of this clinical trial is to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with hypoxic ischemic encephalopathy. The main question it aims to answer is:

1- How do the mesenteric blood flow and oxygenation get affected with MEN during TH? Participants will be either fed with MEN during TH or given placebo.

Detailed Description

Objectives: The investigators aimed to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with HIE.

Methods: This prospective, randomized controlled study was conducted between September 2020 to August 2022. The infants receiving MEN during hypothermia (n =30) and those who were not fed (n=30) constituted the study and control groups. Infants were monitored continuously with NIRS and mesenteric arterial blood flow velocities were measured with Doppler USG before and after feeding.

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-10-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-27
• Last Update Submitted: 2024-03-27
• Study First Posted: 2024-04-03
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The neonates with evidence of encephalopathy de¬fined by seizures or abnormalities on a modified Sarnat exam were enrolled. The hypoxic-ischemic injury was defined by 1. a pH of ≤ 7.0 and/or 2. base deficit >-16 mmol/L recorded in cord blood or blood gas obtained within the first hour postnatally or a pH of 7.0 - 7.15 and/or base deficit (-10-15.9) mmol/L with the presence of an acute perinatal event (cord prolapse, placental abruption, heart rate decelerations, severe fetal bradycardia). In cases where criteria 1 or 2 are met, with the presence of seizures or a diagnosis of moderate to severe encephalopathy according to the Sarnat & Sarnat classification based on neurological examination were treated with TH.

Exclusion Criteria

• Infants with congenital malformation or hereditary metabolic diseases, infants whose enteral feeding was initiated before randomization and infants without lack of parental consent were excluded. The maternal and neonatal demographic characteristics and clinical outcomes were collected from medical records.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infants receiving MEN	Minimal enteral nutrition	The babies fed with minimal enteral nutrition during TH constituted the study group
Infants receiving placebo	Distilled water	The babies who were given distilled water during TH

Primary Outcome Measures

Name	Time	Method
Cerebral and mesenteric blood flow velocities and oxygenation	(From postnatal first day until postnatal 4 th day)Doppler US of SMA and MCA performed before feeding (15-30 minutes before) and 60 minutes after feeding	Cerebral and mesenteric blood flow velocities with Doppler US
Cerebral and mesenteric rSO2 values	(From postnatal first day until postnatal 4 th day) Recording of NIRS data was commenced 60minutes before the initiation of TH and was continued during the procedure till 24 hours after cessation of TH	Cerebral and mesenteric rSO2 values with NIRS

Secondary Outcome Measures

Name	Time	Method
Development of NEC	From admission to NICU till postnatal 15th day or hospital discharge whichever came first,	The infants will be monitorized for NEC development
Feeding intolerance	From admission to NICU till postnatal 15th day or hospital discharge whichever came first,	The infants will be monitorized for feeding intolerance
Time to full enteral feeding	From admission to NICU till postnatal 15th day or hospital discharge whichever came first,	The infants will be monitorized for the time to full enteral feeding.

Trial Locations

Locations (1)

IstanbulTRH; 🇹🇷 Istanbul, Turkey